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FDAAA
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FDAAA is the Most Comprehensive Reform of Prescription Drug Regulation in Decades
On September 27, 2007 President Bush signed into law H.R. 3580, the Food and Drug Administration Amendments Act of 2007 (FDAAA). FDAAA constitutes the most comprehensive reform of prescription drug regulation in four decades. There are few areas of drug and device development and commercialization that are not touched by this reauthorization, and the new authority granted to the FDA is noteworthy.
The impact of this legislation on the pharma/biotech industry will be substantial in multiple areas. Most notable among the gamut of affected areas will be pediatric research, labeling rules, postmarketing surveillance requirements, risk evaluation and mitigation, and direct-to-consumer advertising and marketing. The impact of these new provisions will include but not be limited to: |
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increased costs of drug development, particularly with respect to increased post-approval expenditures |
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more stringent requirements to obtain patent extensions for approved products based on pediatric trials |
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increased requirements for safety assessment, pharmacovigilance, risk evaluation and risk mitigation/minimization |
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broadened access to clinical trial data by the public |
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constrained ability to make marketing claims resulting from more restrictive labeling and tighter review of promotion |
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tighter regulation of DTC messaging |
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What does this mean for 2008?
The impact of the new law will mean that there will likely be higher levels of expenditures required in some areas (especially postmarketing research, drug safety and risk management), more stringent and possibly slower review of approval packages, tougher labeling negotiations, heavier postmarketing commitment burdens (including REMS and RiskMAPs), more stringent review of periodic reports for approved products, and reduced ability to make marketing claims, especially through DTC. In all likelihood, this will translate into shifting of resources toward drug safety, pharmacovigilance, risk management, epidemiology, medical affairs, and other key stakeholder departments engaged in postmarketing safety surveillance and postmarketing research. Regulatory affairs and legal departments in pharma and biotech are likely also grow as companies struggle with the implications of the shifting landscape.
Careful observation of 2008 new product approvals (including time to approval, and rate of approvals) will tell the story of the impact of FDAAA. It is very likely that in the coming year new product approvals may be relatively rare events. New approvals probably will not only occur at lower rates than they have in the past, but when they do transpire, they are likely to be substantially more encumbered. Slower and more cautious regulatory reviews, more restrictive labeling, tighter oversight once approved, and less 'fanfare' and 'flash' for newly launched products once approval occurs are all likely. In short, more stringent and more continuous regulatory review will become the norm, making product lifecycle management substantially more complex.
Covance Periapproval Services — Uniquely Poised to Help
Covance Periapproval Services can help you address the challenges of FDAAA by providing you with the insight you need to:
- Fulfill regulatory commitments
- Expand the safety profile of your product
- Deliver the information you need to support your brand
- Attain rapid, efficient, compliant, and cost-effective completion of every program
The following tools will provide additional insights to this new legislation and answers to many of your questions.
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News
February 12th, 2006
Covance Designs, Manages Industry's Largest Risk Management Plan
New FDA Data Reveals Number of Registered Patients Grows to Nearly 300,000 in First Year, Making Covance-Designed and Managed Risk Management Plan Pharma Industry's Largest |
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